Purpose

This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.

Conditions

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements 2. Subject is > 40 years of age at the time of the discovery of the lung nodule of concern 3. Subject's lung nodule of concern meets the following: - Was incidentally identified or detected during lung cancer screening - Is a solid nodule - Has maximal dimension of > 8mm and < 30mm 4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment 5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less

Exclusion Criteria

  1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern 2. Nodule of concern is part-solid or Ground Glass Opacity (GGO) 3. Prior diagnosis of lung cancer 4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer 5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment 6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern 7. Any illness or factor that will inhibit compliance with study participation

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Open Label Nodify XL2 results will be reported to the investigator and available to the subject.
Blinded Nodify XL2 results will not be available to the investigative site or subject.

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Cindy Mitchell

More Details

Status
Recruiting
Sponsor
Biodesix, Inc.

Study Contact

Niki Givens
7204951583
niki.givens@biodesix.com

Detailed Description

A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as < 50% risk of cancer by Mayo risk prediction algorithm.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.